Recruiting
Phase 1

Envarsus vs. Tacrolimus

Sponsor:

California Institute of Renal Research

Code:

NCT03438773

Conditions

Kidney Transplant; Complications

Kidney Transplant Failure and Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Envarsus

Tacrolimus

Study Details

Brief summary:

This investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at steady state (e.g., trough level at 3 months post conversion) and secondary compliance assessments will be done by pill counts at clinic visits. Secondary outcomes will be the safety of once a day dosing as well as assessment of graft rejection and graft failure. In addition, concentration/dose ratios will be analyzed. The results of this study will provide important information about dosing of once a day tacrolimus (Envarsus) in Hispanic kidney transplant patients, which represents the largest growing group of patients with End-Stage Renal Disease

Conditions

Kidney Transplant; Complications

Kidney Transplant Failure and Rejection

Study ID

NCT03438773

Start date

Jul 11, 2018

Status verified date

Feb, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female 18 years of age or older.
  • The subject is a first time stable renal transplant patients, who have received their transplant at least 3 months before study entry.
  • The subject is willing to commit to the study design.
  • The subject is considered to have stable allograft function defined as no documented rejection episodes within one month of screening.
  • The subject is not currently receiving treatment with other experimental therapies directed at their transplant.

Exclusion Criteria:

  • The subject has undergone a prior organ or bone marrow transplant.
  • The subject has taken any interacting/contraindicated drug determined by the Investigator within 30 days of administration of the protocol.
  • Any study drug allergies and if there are high serum donor specific antibody levels (DSA) or a high panel reactive antibody level (PRA).
  • Documented treatment of rejection within 30 days of onset of the screening visit.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Envarsus

Study group - Envarsus once daily in addition to standard of care.

other: Tacrolimus

Control group - Tacrolimus twice daily in addition to standard of care.

Interventions

Envarsus

Patients randomized into the Envarsus group will be prescribed Envarsus, mycophenolate and prednisone once daily.

Tacrolimus

Patients randomized to the Tacrolimus group will be prescribed Tacrolimus twice-daily with standard of care immunosuppression, anti-proliferative and prednisone once-daily.

Primary outcome measure

  • Tacrolimus drug levels [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Michael C Gastauer

858-810-8155mgastauer@balboaunited.org

Eva Gripp, LVN

858-637-4600EGripp@balboaunited.org

Locations

California Institute of Renal Research

Recruiting

San Diego, California, United States, 92123

Contacts

Eva Gripp, LVN

858-637-4600EGripp@balboaunited.org

Karina Maldonado

858-810-8083KMaldonado@balboaunited.org

Principal Investigator:

Arman Faravardeh, MD

More Information

Sponsor

California Institute of Renal Research

Last update posted

Feb 9, 2023

Last verified

Feb, 2023

Keywords

  • Hispanic
  • First time kidney recipients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by California Institute of Renal Research on 2023-02-09.